Facts and Issues of Submitting Applications (Public Knowledge-Based Applications) for Unapproved and Off-label Drugs With High Medical Needs in Japan
This study suggests that the availability of existing domestic therapies and the approval or standard use status of a drug in the 6 Western countries influence the judgment of the applicability of public knowledge-based applications.
Authors
- Hiromu KUTSUMI
- Daisuke Obata
- Jun Matsubayashi (ORCID: https://orcid.org/0000-0001-7545-9332)
- Mayumi Yamanaka
- Akiko Hinomura
- Shu Kasama
- Shin-ya Morita
- Koji Yamada
- Rumiko Hosoki
Institutions
- Ritsumeikan University (JP)
- Shiga University of Medical Science (JP)
- Kobe University Hospital (JP)
- Asahi Kasei (Japan) (JP)
- Akashi Municipal City Hospital (JP)
Publication Details
- Journal
- Current Therapeutic Research
- Published
- 2026-01-02
- DOI
- https://doi.org/10.1016/j.curtheres.2025.100819
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 0.00